ModifiedCentenePolicy CP.MP.147

Percutaneous Left Atrial Appendage Closure Device for Stroke Prevention

Defines medical necessity and coverage criteria for FDA‑approved percutaneous LAA occlusion devices (WATCHMAN, WATCHMAN FLX, Amplatzer Amulet) to reduce stroke risk in adults with non‑valvular atrial fibrillation, and states noncoverage stance for non‑approved devices.

Policy Summary

PayerCentene

PolicyPercutaneous Left Atrial Appendage Closure Device for Stroke Prevention

Policy CodePolicy CP.MP.147

Change TypeMaterial revisions — devices added and criteria clarified

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for CPT 33340 with documentation that all policy criteria are met.

SourceLink

POLICY UPDATE CHANGES

Updated criteria to include all FDA approved percutaneous devices for occlusion of the LAA (WATCHMAN, WATCHMAN FLX, Amplatzer Amulet) and removed verbiage that the WATCHMAN is the only FDA approved device.

Changed criteria I wording to require 'all' of the following and added criterion I.C 'Ability to tolerate short‑term anticoagulants'; removed prior enumerated contraindications I.B.1‑I.B.11 and removed note that warfarin may be required.

Replaced prior wording that other percutaneous devices are 'investigational' with a statement that there is a paucity of evidence regarding their long‑term safety and efficacy and that no other devices are FDA approved for this indication.

3FDA‑approved devices named

33340Referenced CPT code

≈10%

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Coverage Criteria — Percutaneous LAA Occlusion

Initial therapy (medically necessary)

Covered when ALL of the following are met:

Medically necessary criteria: There is an increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, and long-term anticoagulation therapy is recommended.

Applies to adults with non-valvular atrial fibrillation and FDA-approved percutaneous LAA occlusion devices (WATCHMAN, WATCHMAN FLX, Amplatzer Amulet).

Medically necessary criteria: Contraindications to, or an unacceptable high risk of bleeding from, long-term oral anticoagulants.

Documentation should support rationale for why long-term anticoagulation is contraindicated or not tolerated.

Medically necessary criteria: Ability to tolerate short-term anticoagulants.

Patient must be able to receive short-term anticoagulation per procedural/IFU guidance.

Devices not covered / not supported

Non-approved devices: Current research does not support the use of percutaneous devices other than WATCHMAN, WATCHMAN FLX, and Amplatzer Amulet for occlusion of the left atrial appendage to reduce stroke risk in adults with non-valvular atrial fibrillation; no other devices are FDA approved for this indication.

There is a paucity of evidence regarding long-term safety and efficacy for other percutaneous LAA devices.

This policy clarifies that only FDA‑approved percutaneous left atrial appendage (LAA) occlusion devices — specifically WATCHMAN, WATCHMAN FLX, and Amplatzer Amulet — are considered medically necessary for reducing stroke risk in adults with non‑valvular atrial fibrillation when all clinical criteria are met (increased stroke risk by CHADS2/CHA2DS2‑VASc, contraindication or unacceptable bleeding risk with long‑term oral anticoagulants, and ability to tolerate short‑term anticoagulation). Devices not specifically FDA‑approved for LAA occlusion are outside the scope of covered therapy under this policy because current research and regulatory approval do not support their use for this indication.

Percutaneous devices other than the named FDA‑approved systems are not supported by this policy due to a paucity of evidence regarding their long‑term safety and efficacy; the policy explicitly states that no other percutaneous devices are FDA approved for this indication, and therefore such devices are not considered medically necessary for stroke prevention in this population.

State Medicaid coverage provisions and any applicable state or federal requirements take precedence over this clinical policy where conflicts exist. Providers and billing staff should consult the relevant state Medicaid manual and the Health Plan’s administrative coverage documents for state‑specific rules, as the policy serves as a medical‑necessity guide but does not replace contractual coverage terms or regulatory mandates.

The policy further reminds providers that coverage determinations are subject to the Health Plan’s terms, conditions, exclusions, and limitations; when submitting prior authorization requests or claims, follow the Health Plan’s procedures and the state Medicaid guidance as applicable.

Use of percutaneous LAA occlusion devices that are not FDA approved for this indication is considered not supported by current research and therefore would not meet the policy’s coverage criteria. The document replaces prior language that labeled such devices as "investigational" with clearer findings that there is a paucity of evidence regarding long‑term safety and efficacy for other percutaneous devices, and reiterates that at this time no additional devices have FDA approval for LAA occlusion.

Consequently, requests for coverage of non‑approved devices should be expected to be denied under this clinical policy unless and until robust evidence and regulatory approval for other devices are available.

Coding and Risk Scores

Referenced CPT CodesCPT

33340

Percutaneous transcatheter closure of the left atrial appendage with endocardial implant, including fluoroscopy, transseptal puncture, catheter placement(s), left atrial angiography, left atrial appendage angiography, when performed, and radiological supervision and interpretation

Stroke risk scores — CHADS2 / CHA2DS2‑VASc

Stroke risk assessment toolsPolicy references CHADS2 and CHA2DS2-VASc scores to determine increased stroke risk and need for long-term anticoagulation.

Action tied to scoreAn increased score on CHADS2 or CHA2DS2-VASc indicating that long-term anticoagulation is recommended is required as part of medical necessity for LAA occlusion devices.

Guideline sourceACC/AHA/HRS guideline endorses CHA2DS2-VASc for estimating stroke risk in AF and for guiding anticoagulation decisions referenced in the policy.

Documentation requirementPatient record must document CHADS2 or CHA2DS2-VASc score as evidence of increased stroke risk when requesting device coverage.

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for percutaneous left atrial appendage (LAA) closure procedures using FDA‑approved devices. Obtain prior authorization before scheduling procedures coded to CPT 33340.

Affected CPT: 33340
Applicable devices: FDA‑approved percutaneous LAA occlusion devices (e.g., WATCHMAN, WATCHMAN FLX, Amplatzer Amulet)

Note

Prior Authorization Guidance

Coverage decisions are guided by the policy medical necessity criteria and plan-level administrative policies. Providers should follow the Health Plan's authorization and coverage procedures; inclusion of codes in this policy is informational and does not guarantee coverage.

Refer to plan-level administrative policies for submission requirements
Coverage subject to terms, conditions, exclusions, and limitations of the member's benefit documents

Background and Clinical Context

Atrial fibrillation substantially increases the risk of ischemic stroke; in patients with non‑valvular AF the left atrial appendage (LAA) is the predominant site of thrombus formation. Mechanical exclusion of the LAA with percutaneous occlusion devices provides an alternative strategy to long‑term anticoagulation for patients at elevated stroke risk who have contraindications to chronic oral anticoagulants.

FDA‑approved devices such as WATCHMAN, WATCHMAN FLX, and Amplatzer Amulet have been studied in randomized trials and large registries demonstrating stroke prevention comparable to anticoagulation in selected patients, though procedural complications (for example, pericardial bleeding observed in early studies) and operator experience are important considerations when evaluating candidacy for LAA occlusion.

Device therapy under this policy is intended for adults with non‑valvular AF who have an increased stroke risk (per CHADS2 or CHA2DS2‑VASc) and either contraindications to or unacceptable bleeding risk with long‑term anticoagulation, provided the patient can tolerate short‑term anticoagulants required peri‑procedurally.

Definitions

CHA2DS2‑VASc score — definition and components

DefinitionCHA2DS2-VASc is a clinical point score estimating stroke risk in atrial fibrillation based on Congestive heart failure, Hypertension, Age ≥75 years (2 points), Diabetes, prior Stroke/TIA/thromboembolism (2 points), Vascular disease, Age 65–74 years, and Sex category.

Use in policyUsed to estimate stroke risk and determine when long-term anticoagulation is recommended as part of patient selection for LAA occlusion.

Threshold guidancePer cited guideline in the policy, oral anticoagulation is a class I recommendation for patients with prior stroke/TIA or a CHA2DS2-VASc score >2.

Non‑valvular atrial fibrillation — definition used in policy

Definition used in policyNon-valvular atrial fibrillation is atrial fibrillation not related to moderate to severe mitral stenosis or mechanical heart valves; it is the population for which percutaneous LAA occlusion devices are indicated in this policy.